Dr. Thomas Anthony McNicholas from the Royal Society of Medicine in England recently reviewed the clinical evidence of the UroLift system and procedure. The device was approved by the U.S. FDA in September 2013 and by the U.K. National Institute for Clinical and Health Excellence in September 2015 for the management of male lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

The review article, “Benign prostatic hyperplasia and new treatment options – a critical appraisal of the UroLift system,” was published in Medical Devices: Evidence and Research.

First-in-line therapies for the management of LUTS usually include medication, but such drug treatments can lead to side effects such as dizziness, headache, and sexual dysfunction.

In patients unresponsive to drug therapies or who develop related complications, surgeries that cut or ablate prostate size are the alternative, such as transurethral resection of the prostrate (TURP). Despite high success rates in relieving symptoms, this surgery is also associated with side effects, including bleeding, incontinence, and erectile dysfunction.

The need for new treatment alternatives gave rise to the UroLift system, a minimally invasive technology to treat BPH-related LUTS. The system consists of permanent implants designed to relieve prostate obstruction and open the urethra without cutting, heating, or removing prostatic tissue. Importantly, the system is implanted in a quick procedure feasible with local anesthesia, with or without sedation.

Clinical data on this U.S. FDA-cleared system shows that patients with enlarged prostates receiving the UroLift system show significant improvements in symptom management, urinary flow rate, and quality of life without compromising sexual function. Most adverse events, mild to moderate in severity, disappeared within two to four weeks after the procedure.

The system is available in the U.S., Europe, Australia, Canada, and Mexico. Following a positive NICE (National Institute for Health and Care Excellence) review in 2015, based on its cost-effectiveness and clinical benefits, UroLift is now being offered by multiple publicly-funded NHS hospitals in the United Kingdom.

The review provides a clear overview of the more recent studies that demonstrate the system’s safety and efficacy, especially as an alternative to surgery for symptomatic men who do not want, respond, or tolerate long-term drug treatments and who wish to preserve sexual function.

“UroLift has the distinction of being highly unusual in the field of urinary device treatments in that it has been introduced into clinical practice with evidence of safety and efficacy rather than being introduced and sold before such evidence had been accumulated,” the author wrote in the final remarks.